Addyi is a new libido-boosting pill for women. According to the manufacturer’s studies, it can restore a healthy sex drive to some (but not all) of the women who take it daily. But the drug is expensive and has scary side effects. So is Addyi worth it?

But the downsides could be forgiven in a drug that truly works. Low libido is a real problem for many women, although experts disagree on the best way to treat it. Addyi’s maker, Sprout, has backed a marketing campaign that argues drugs like Addyi are desperately needed. Meanwhile, critics say Sprout is unfairly positioning normal sexuality as a disease to create demand for its pills.

What Addyi Can and Can’t Do

First things first, even though it’s been called the “female viagra,” Addyi is nothing like Viagra. Flibanserin works more like an antidepressant, which once upon a time it was intended to be. (That didn’t work out.)

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Like antidepressants, flibanserin doesn’t act instantly: you need to take it for weeks or months to alter your brain chemistry. That’s the first difference between Addyi and Viagra: men take Viagra on days they want to have sex, and it increases blood flow to the penis within an hour. Women take Addyi every day, indefinitely, in the hopes that after a month or two they might want sex more.

The FDA’s approval decision was based on studies conducted and funded by the drug’s maker, but designed according to requirements the FDA set out. This is pretty standard for new drug applications. The studies haven’t all been published in journals, but this briefing document includes the key results.

In Sprout’s three preciously-named trials—DAISY, VIOLET, and BEGONIA—women who took flibanserin for six months ended up having “satisfying” sexual events (including sex and masturbation) more often than before the trial. On average, the effect size was small. For example, in BEGONIA, the women had 2.5 more satisfying sexual events per month, on average. But women in the control group also had more sex—in that case, 1.5 more events, meaning the drug added one per month.

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But those are averages. Some women responded well to Addyi, adding an extra satisfying sexual event each week. On the other hand, most women who took it saw no improvement at all. Only a few responded to the drug—between 7 and 13 percent. Sprout recommends that women try the drug for two months and stop taking it if they don’t see a benefit.

Only that small percentage will owe the effects to a biological response to the drug, but far more women will seem to improve. Here’s what that means. In BEGONIA, 46% had more sex than before the trial when they were taking Addyi—but so did 36% on placebo, the inactive pill used as a comparison. We can say the drug added the extra 10%, but there’s no way to know who in that group benefited because of the drug and who owes their extra sexytimes to a placebo effect.

That “placebo effect” isn’t bogus—it includes things like the effects of thinking about your sexual feelings on a daily basis. Women in the studies had to answer a few questions about their sex lives each night, and talked to researchers and perhaps also to their partners about it. Something similar happened in this trial of oxytocin for sexual dysfunction published in Fertility and Sterility: oxytocin didn’t work any better than placebo, but women in both groups had more and better sex. Michaela Bayerle-Eder, the lead researcher, told Think Progress that what the trial really showed was the power of partner communication.

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The Risks of Addyi

What’s more concerning are the risks. The drug can cause sedation, sleepiness, and dizziness, so Sprout recommends taking it at bedtime. Sprout’s most recent FDA application included a study of how safely women could drive in the morning after taking Addyi at bedtime, and fortunately they were able to drive just fine.

Addyi can also cause women to develop low blood pressure, and (rarely) to faint at seemingly random times. This only happened to a few people in the studies, but regulators were, understandably, extremely concerned. You’re more likely to experience this effect if you drink alcohol. Sprout conducted a study to see what happens when you combine flibanserin with alcohol...and somehow managed to conduct it in mostly men.

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“In terms of the alcohol study, we didn’t have the foresight to require only women,” their spokesperson said. And no, this wasn’t from deep in flibanserin’s history as a unisex drug; the FDA requested the study when they rejected flibanserin as a women’s libido pill in 2010. Walid Gellad, a member of the FDA’s advisory panel, called the 23-to-2 sex ratio in the study a “huge disappointment.” Women metabolize alcohol differently than men, which means we don’t know much about this interaction in the people who will actually take it.

Nonetheless, women taking the drug are expected to abstain from alcohol. Not just on occasion, but completely. That means that if you’re used to having a glass of wine to help you relax or get in the mood—or if you just like to drink because, hey, that’s a normal thing to do—that option is now off limits to you.

Can Low Libido Be Treated With Medication?

There are definitely women who feel they have a sex drive low enough that it interferes with their lives. What’s less clear is whether it’s appropriate to treat that condition with medication at all, and if so, whether Addyi was studied in a way that lets us know if it will truly help these women.

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The condition Addyi was designed to treat is known as HSDD: Hypoactive Sexual Desire Disorder. The name implies that women should experience some normal level of desire, and that it’s a medical problem if they feel that their desire is low.

Essentially, the drugmaker is assuming that spontaneous, “out-of-the-blue” desire for sex is the only “normal” way to experience desire, and that is, according to the accumulated science of the last 20-30 years, not true. Instead, most people experience spontaneous desire sometimes and RESPONSIVE desire other times.

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Responsive desire means that desire can be an effect, and not just a cause, of experiencing sexual pleasure. Nagoski likes the analogy of going to a party: maybe you aren’t sure if you feel like going—there’s traffic, you’ll have to put on pants and leave the house—but as soon as you get to the party you have a great time. Having a similar attitude toward sex is healthy and normal, she argues. Women who feel this way aren’t broken and don’t need a drug.

The doctors and patients who spoke at an FDA meeting earlier this year described HSDD in terms that sound like a textbook definition of responsive desire:

“[W]e know that women [with HSDD] can have a satisfying sexual event...what [these] women are missing is the desire, the wanting, the appetite for sexual activity. And women will choose to have sexual events that eventually are satisfying for a variety of reasons. What they miss is the reward system that then wants them to want it again.”

Flibanserin is potentially helpful for women who don’t have any type of desire. It’s not known how many women might fall into this category, but it’s probably a lot less than the 43% of women said to have “sexual problems.” (That number comes from a study that judged things like not looking at porn to be a problem). Sprout now uses a 10% number in their marketing. Nagoski guesses the truth is closer to 6%.

So were the women in Sprout’s trials actually experiencing a real problem that medication should be able to fix? Before they started the drug, they were having “satisfying sexual events” 2.5 times per month, which is actually pretty average for married women their age. It’s also not clear if increasing those events meant that women were enjoying sex more. As Sprout researcher David Portman explained:

“[E]ven if a woman is reporting an SSE, a satisfying sexual event, we heard here at the patient-focused meeting last October that women often said, I was satisfied because I satisfied my obligation.”

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In other words, the “obligation” she feels to her husband.

A key component of HSDD is that it causes distress to the patient. On the one hand, it’s great that the diagnosis leaves it up to the woman herself to decide when lack of desire is a problem. But the weakness of this approach is that there’s no reality check on what should be considered a problem at all.

Many of the women who spoke at the FDA meetings said that their “distress” was often due to guilt about disappointing their partners. This adds even more confusion to the question of effectiveness: is the drug really helping women have better sex, or just guilting them into having it more often? The trial data don’t give us enough information to tell the difference.

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Addyi’s studies also didn’t address a crucial question: if low sex drive is a problem for you, should you choose Addyi over other treatment options? Investigators only tested the drug against an inactive placebo, and not against other treatments. Sex therapy can be an effective treatment for low libido, but the subjects in the Addyi trials were actually excluded if they had had any kind of talk therapy in the past three months. What’s even more shocking: only a few dozen out of the thousands had ever tried therapy. Were they seeking medication when what they really needed was a better understanding of their own sexuality?

And while there isn’t a true female equivalent to Viagra, doctors who see patients with low libido have been prescribing a few treatments “off label” that help some women. Drugs used this way include the antidepressant bupropion, which seems to enhance reward pathways in the brain, and testosterone.

Obstetrician-gynecologist Alyssa Dweck says she sees Addyi as a “welcome addition” to the current options for medication, lifestyle changes, therapy, and counseling.

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Will It Work for Me?

Addyi can probably benefit some people, but it’s still not really clear who or by how much.

There’s a lot we don’t know about Addyi’s effects in real world settings: for example, whether there will still be a large placebo effect, and how well the drug will work in women who don’t match the population tested in the trials.

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Those women were all premenopausal, heterosexual, mostly white, and all in stable, monogamous relationships that were otherwise happy. These women were excluded from the trials if they had depression or any other conditions that might affect their sexuality, or if they were taking other medications, like antidepressants, that might have sexual side effects.

The decision to take Addyi (or, really, to try any of the current treatments for low libido) is something of a gamble—you’re betting that you have a type of low libido that Addyi can treat, and that you’re one of the responders. That’s in addition to the concerns about side effects. But there’s one other important question about taking this shiny new pill: Can you afford it?

What Does Addyi Actually Cost?

Shortly before the drug hit the market, I contacted its maker, Sprout Pharmaceuticals, to ask a few simple questions, including the price of the drug. Their PR folks refused to tell me before the product launch, but volunteered instead that there would be an assistance program to help people get Addyi for “as little as” $20 per month.

You know it’s bad when a pharmacist—who, of all people, should be immune to sticker shock—pauses for a good couple seconds and says “Ooooh, that one’s pricey.” At that pharmacy, a Walgreen’s, a month’s supply out of pocket would cost $971.09.

But Addyi’s maker doesn’t intend for you to pay for it out of pocket. They have a different business model in mind, one that is getting them investigated by federal prosecutors. It involves semi-secret prices, co-pay assistance, and a network of pharmacies that they directly control.

In this case, Addyi is a brand new drug, so we don’t know what its price would have been before the takeover. But Valeant deployed its other two trademark moves on Addyi: assistance programs and a captive pharmacy.

Here’s how the assistance program works: you download a coupon to bring to the pharmacy. If you have insurance that covers the drug, you pay $20 of your co-pay and Valeant covers any remainder. The offer is good for your first seven monthly prescriptions. If you have insurance that doesn’t cover Addyi, you still only pay $20 and Valeant pays the rest, essentially buying its own drug from itself. (The fine print limits Valeant’s contribution to $780, suggesting that my local pharmacy’s price isn’t a fluke—the sticker price must be $800 or more)

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By the time the deal is up, you’ll have had a chance to decide if it works for you—remember that it takes a month or two to see the effects and that nearly half of women had some kind of positive response (even though all but 10% would have had the same response with an appropriately-hyped tic-tac). They are probably also planning to use the time to convince more insurers to add coverage for Addyi.

You love it because you get the drug for cheap. Your doctor loves it because you don’t complain about the drug being expensive. The drug company loves it because they still make a ton of money. But Valeant is still screwing you over—just belatedly and indirectly.

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First, the assistance program maxes out after a few months, and Valeant reserves the right to cancel the program without notice at any time. This means that several months into taking this long-term therapy, you’ll find it suddenly costing you the full sticker price.

And even while Valeant is paying, your insurance company is wasting money on an overpriced drug. Many private insurance companies put up with these assistance programs, although they are prohibited under Medicare. To pay for your (and everybody else’s) Addyi prescriptions, the insurance company will eventually have to charge you more for coverage. Hidden drug costs are a major factor behind rising premiums. So, while it seems like you aren’t paying full price for the drug, you still get stiffed in the end.

Until this week, Valeant had an even sleazier program going on: they were encouraging everyone to fill their prescriptions, not at the neighborhood Walgreen’s, but from a “captive pharmacy”: a mail-order drugstore controlled by the drug maker. These pharmacies help keep prices high by filling prescriptions through the assistance program whenever possible, and only selling the company’s drugs rather than competitors’ or generics. (Addyi doesn’t have a generic equivalent, but many of Valeant’s other high-priced drugs do.) For Addyi, there’s also a real benefit in giving patients easy access to a certified pharmacy in case there isn’t one in their neighborhood.

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With the captive pharmacy, the assistance program offered even better terms: there was no time limit if you had insurance, and even people who were totally uninsured could get the drug for a mere $150. But Valeant was recently accused of fraud, and federal prosecutors are investigating whether its pharmacy shenanigans and price gouging are done legally—because everything described so far is, amazingly, legal—or whether they’ve added layers of criminal wrongdoing on top of that. The pharmacy that ran Addyi Direct, called Philidor, is at the center of the accusations.

In a few months, the first patients to use Addyi outside of clinical trials will be able to decide if it’s helped them (and whether, after Valeant’s grace period, they can still afford it). In a few years, we’ll know whether the safety issues are more or less serious than the trials suggested. We’ll also get the results of the post-approval studies the FDA is requiring Sprout to do, including a redo of the alcohol study—but in women this time.

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So is Addyi worth the risks, cost, and uncertainty? For most women, probably not—but only time will tell.